BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR, PL 1.5

    MDR report key: 3012882 · Received March 1, 2013

    Report

    Report Number
    2021898-2013-00077
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET REQUIREMENTS FOR THE SIPHON, REFLUX, PREIMPLANTATION, AND LEAKAGE TESTS. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. IT ALSO MET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTINGS. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. A 99.1 CM OF THE CARDIAC/PERITONEAL CATHETER AND 13.3 CM OF THE VENTRICULAR CATHETER WERE RETURNED. BOTH CATHETERS MET REQUIREMENTS FOR THE PATENCY AND LEAKAGE TESTS. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE IMPLANTATION OPERATION THE PHYSICIAN FOUND THAT THE "CHAMBER LEAKED." THEY USED A DIFFERENT SHUT KIT TO COMPLETE THE OPERATION. IT WAS ALSO REPORTED THAT THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90497 DELTA SHUNT KIT, REGULAR, PL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D29933

    Patients

    Seq Age Sex Outcome Treatment
    1